Posted by Michael Wonder on 30 Nov 2018
FDA announces pilot program with WHO to expedite review of HIV drug applications
30 November 2018 - The U.S. FDA today announced a plan to work with the WHO to pilot a process to share documents on HIV drug applications that have been approved or tentatively approved by the agency under the U.S. President’s Emergency Plan for AIDS Relief.
In this initial pilot, to be called the Collaborative Registration Procedure-Lite (CRP-Lite), the FDA will, with the applicants’ permission, provide the WHO/PQP with minimally-redacted reviews of one or two HIV drug applications.
The WHO/PQP will then use the FDA’s reviews to expedite its own regulatory decision making, producing review dossiers which can in turn be shared with regulators in resource limited countries to speed up their own regulatory review processes—making lifesaving drugs available to patients who need them the most.
